Feb 15, 2016

Cartiva Announces First UK Patient Treated in Study of Cartiva® SCI for Pain Associated with Osteoarthritis of the Thumb

Study to Evaluate Safety and Effectiveness of Cartiva SCI in the treatment of first carpometacarpal (CMC) joint osteoarthritis

Cartiva, Inc., a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced that the first patient in the United Kingdom has been treated in its GRIP Study, a multi-center study evaluating the safety and effectiveness of Cartiva Synthetic Cartilage Implant (SCI) in the treatment of first carpometacarpal (CMC) joint osteoarthritis at the base of the thumb. Mr. Chris Bainbridge, MB ChB, FRCSEd, the Co-Principal Investigator of the GRIP Study, performed the surgery at The Pulvertaft Hand Centre within the Royal Derby Hospital in Derby, England.

Cartiva SCI is a proprietary hydrogel polymer device designed to mimic natural cartilage. The implant is used in the treatment of osteoarthritis in patients with diseased or damaged articular surface in the first CMC joint. Cartiva SCI is implanted in the metacarpal base, where its placement provides replacement for damaged cartilage without requiring the destruction or removal of a patient’s healthy tissue. The design of the Cartiva implant minimizes bone resection and preserves the trapezium and may provide for a quicker and less painful recovery than ligament reconstruction tendon interposition (LRTI) surgery or trapeziectomy. Also, because the procedure preserves normal joint anatomy, LRTI or trapeziectomy remain viable options if a revision is ultimately required. The Cartiva implant is currently available in Europe and Canada.

"We are excited to have treated the first UK patient in this multicenter study, said Mr. Bainbridge, Consultant Hand Surgeon at the Pulvertaft Hand Centre. “Cartiva SCI is an innovative implant that may offer advantages over current procedures. Evaluating new technology with the goal of improving patient outcomes is part of our ongoing effort to deliver the best patient care possible."

About the GRIP StudyThe GRIP study is a prospective feasibility Phase II study to evaluate the safety and effectiveness of Cartiva SCI in the treatment of first carpometacarpal (CMC) joint osteoarthritis. The objectives of the study are to evaluate the safety and effectiveness of Cartiva SCI for CMC in terms of pain relief and improvement of joint function and to evaluate Cartiva SCI for CMC device performance in order to establish the parameters for a pivotal trial. A total of 50 patients will be treated with Cartiva at ten sites across Canada and the United Kingdom. Participating sites and principal investigators include the following:

Participating Institution

Location

Principal Investigator

United Kingdom:

Royal Derby Hospital

Derby, England

Chris Bainbridge, MD

Royal United Hospital

Bath, England

Grey Giddins, MD

South Tees Hospitals NHSFoundation Trust

Middlesbrough, England

Sanjay Miranda, MD

Queen Alexandra Hospital

Portsmouth, England

Philip Sauvé, MD

Woodend Hospital

Aberdeen, England

David Lawrie, MD

Canada:

QEII Health Sciences Centre

Halifax, Nova Scotia

Andrew Trenholm, MD

University of British Columbia,Vancouver

Vancouver, British Columbia

Erin Brown , MD

University of Calgary

Calgary, Alberta

Jonathan Lee, MD

Sunnybrook Health Sciences Centre

Toronto, Ontario

Paul Binhammer, MD

University of Alberta

Edmonton, Alberta

Mike Morhart, MD

About Osteoarthritis of the CMC JointAlso known as thumb basal joint arthritis, osteoarthritis of the CMC joint is a common and frequently debilitating condition that affects 8% to 12% of the general population and as many as 33% of postmenopausal women. Osteoarthritis of the CMC joint causes pain, swelling, instability, deformity, loss of motion and weakness, making it difficult to perform a variety of tasks, such as turning doorknobs and opening jars. Current surgical options for later-stage patients for whom conservative treatments have failed include joint fusion, total or partial trapeziectomy or arthroplasty.